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Clinical and Basic Research on the Treatment of Polycystic Ovary Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04120597
Recruitment Status : Not yet recruiting
First Posted : October 9, 2019
Last Update Posted : February 24, 2021
Information provided by (Responsible Party):
Ruining Liang, Jiangxi University of Traditional Chinese Medicine

Brief Summary:
Polycystic ovary syndrome is the most common endocrine and metabolic disorder in gynecology. Traditional Chinese medicine has a good clinical effect in the treatment of PCOS. We intend to conduct this trial in strict accordance with the requirements of evidence-based medicine, through a multi-center, randomized, controlled study, using a double-blind, randomized, placebo-controlled study design method to clarify that Zishen Qingre Lishi Huayu Recipe restores spontaneous ovulation in PCOS patients. The overall efficacy of improving the characteristics of Kaohsiung and glucose and lipid metabolism is optimal, and high-level evidence-based evidence is obtained to form a diagnosis and treatment plan for promotion.

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Drug: Zishen Qingre Lishi Huayu Granules Drug: Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical and Basic Research on the Treatment of Zishen Qingre Lishi Huayu Method on Zin Deficiency and Dampness Type Polycystic Ovary Syndrome: a Multi-center, Double-blind, Randomized and Placebo-controlled Study
Estimated Study Start Date : March 6, 2021
Estimated Primary Completion Date : November 1, 2021
Estimated Study Completion Date : November 30, 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Therapy group Drug: Zishen Qingre Lishi Huayu Granules
The treatment group used Zishen Qingre Lishi Huayu Granules, including Zhimu(Anemarrhena asphodeloides Bge.), Shengdi(Rehmannia glutinosa Libosch.), Maidong(Ophio pogon japonicus (L.f) KerGawl.) , Bixie(Dioscorea septemloma Thunb.), Huanglian(Coptis chinensis Franch.), Zhuling(Polyporus umbellatus(Pers.)Fries), Xuanshen(Scrophularia ningpoensis Hemsl.), Zelan(Lycopus lucidus Turcz. Var. Hirtus Regel), Danshen(Salvia miltiorrhiza Beg.), Gancao(Glycyrrhiza uralensis Fisch.). Subjects take the drug from the first day of inclusion. Take 1 pack each time, bid, for 3 months.

Placebo Comparator: Control group Drug: Placebo

The treatment group used Caramel pigment、 Ku Ding Cha Extracts、Maltodextrin、Starch and 5% Zishen Qingre Lishi Huayu Granules .

Subjects take the drug from the first day of inclusion. Take 1 pack each time, bid, for 3 months.

Primary Outcome Measures :
  1. Ovulation rate [ Time Frame: The 3rd month ]
    Ovulation rate of each group during the study period Ovulation rate per group = actual total ovulation frequency / total number of cycles (total number of cycles = number of samples).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Diagnosed as PCOS patients, the diagnostic criteria is: modify the Rotterdam criteria. All subjects must have: no ovulation, combined with polycystic ovarian or / and hyperandrogenism.
  2. Age: 20 to 40 years old, no maternity requirements.
  3. Willing to be treated according to the treatment plan specified in this study.

Exclusion Criteria:

  1. Hyperprolactinemia: In the past year, patients with normal levels can be included.
  2. Menopausal FSH levels:FSH > 15 mIU/mL. In the past year, patients with normal levels can be included.
  3. Patients with thyroid disease: TSH < 0.2 mIU/mL or >5.5 mIU/mL. In the past year, patients with normal levels can be included.
  4. Patients with poorly controlled type 2 diabetes:HbA1c>7.0%, or patients receiving antidiabetic drugs.
  5. Patients currently diagnosed with severe anemia (HGB <10 g/dL).
  6. Patients with a history of alcohol abuse: Alcohol is defined as drinking 14 times a week or more or binge drinking.
  7. Currently suspected Cushing's syndrome patients.
  8. Patients suspected of having adrenal or ovarian tumors secreting androgen.
  9. In patients with hypertension who are currently untreated or have poor blood pressure control, the interval between two blood pressure measurements is ≥ 60 min, systolic blood pressure ≥ 160 mm Hg or diastolic blood pressure ≥ 100 mm Hg.
  10. Patients currently diagnosed with metabolic syndrome
  11. Take hormonal drugs, Chinese medicine prescriptions and proprietary Chinese medicines in the last 3 months.
  12. There is a history of pregnancy in the last 6 weeks.
  13. Abortion or production history in the last 6 weeks.
  14. A history of breastfeeding in the last 6 months.
  15. Patients with a history of deep vein thrombosis, pulmonary embolism or cerebrovascular disease.
  16. Patients with severe primary diseases such as cardiovascular, liver, kidney and hematopoietic system, and mental patients
  17. Patients who are expected to discontinue treatment during the trial or who are unable to adhere to treatment for 3 months should be excluded.
  18. Reluctant to sign the informed consent form for this study.
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Responsible Party: Ruining Liang, chief physician, Jiangxi University of Traditional Chinese Medicine Identifier: NCT04120597    
Other Study ID Numbers: S2018ZPYFE0937
First Posted: October 9, 2019    Key Record Dates
Last Update Posted: February 24, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Pathologic Processes
Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases